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Can I read The Application of in Vitro Methods to Safety Pharmacology on EtoBox?
The Application of in Vitro Methods to Safety Pharmacology by Ian D. Wakefield; Chris Pollard; William S. Redfern; Timothy G. Hammond; Jean-Pierre Valentin is a Medicine article available to read on EtoBox.
What is The Application of in Vitro Methods to Safety Pharmacology about?
The ICH S7A guideline defines safety pharmacology (SP) studies as those that investigate `the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above', and permits both in vivo and in vitro techniques, as appropriate. The implementation of these ICH guidelines by the pharmaceutical industry – whilst providing a welcome and long overdue clarity into the scientific rationale, timing and regulatory requirements for SP studies – has also generated new challenges, both logistical and scientific, which have a major impact on drug development. These factors have motivated us to consider the introduction of in vitro techniques at an early stage of SP evaluation. Amongst these factors are: the expanded range of study types and physiological parameters to be assessed, the increased `front‐loading' of SP at earlier stages of the drug discovery process; the greater number of new chemical entities (NCEs) to be tested, together with limited compound supply; the condensed time frames for drug development, the higher and quicker throughput of in vitro vs. in vivo tests; the increasing predictability of in vi
Who reads The Application of in Vitro Methods to Safety Pharmacology?
It is typically read by researchers, students, and practitioners in Medicine.
- Author
- Ian D. Wakefield; Chris Pollard; William S. Redfern; Timothy G. Hammond; Jean-Pierre Valentin
- Publisher
- John Wiley and Sons; Wiley (Blackwell Publishing); Blackwell Publishing Inc.; Wiley (ISSN 0767-3981)
- Published
- 2002
- Language
- EN
- Field
- Medicine (Health Sciences)